TriangleNCT04222972 · STUDY IN CONTEXT
A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
PFS was defined as the time from randomization to the date of first documented PD as determined by the investigator with the use of Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD at prior timepoints, including baseline. In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of at least 5 millimeters (mm). Kaplan-Meier (K-M) method was used to estimate median PFS. 95% CI for median was computed using the method of Brookmeyer and Crowley.
ORR was defined as the percentage of participants with a complete response (CR) or a partial response (PR) on two consecutive occasions ≥4 weeks apart, as determined by the investigator with the use of RECIST v1.1. CR was defined as disappearance of all target lesions or any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. 95% CI for rates were constructed using the Clopper-Pearson method. Percentages have been rounded off.
OS was defined as the time from randomization to death from any cause. K-M method was used to estimate median OS. 95% CI for median was computed using the method of Brookmeyer and Crowley.
An AE is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.
ECOG is a 6-point scale (0-5) used to assess participants functional status, where, 0= Fully active, able to carry on all pre-disease performance without restriction; 1= restricted in physically strenuous activity but ambulatory \& able to carry out work of a light or sedentary nature, e.g., light housework, office work; 2= ambulatory \& capable of all self-care but unable to carry out any work activities. Up \& about more than 50% of waking hours; 3= capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5= dead.
DOR was defined as the time from the first occurrence of a documented objective response (OR) to PD or death from any cause, whichever occurred first, as determined by the investigator with the use of RECIST v1.1. CR was defined as disappearance of all target lesions or any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. K-M method was used to estimate median DOR. 95% CI for median was computed using the method of Brookmeyer and Crowley.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-thoracic-neoplasm
- nct id
- NCT04222972
- trial label
- A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 3
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-thoracic-neoplasm
- nct id
- NCT04222972
- outcome key
- om-0000
- source section id
- NCT04222972-om-0000
- source outcome index
- 0
- endpoint
- Arm A vs Arm B: Treatment Period: Progression-free Survival (PFS)
- endpoint definition
- PFS was defined as the time from randomization to the date of first documented PD as determined by the investigator with the use of Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD at prior timepoints, including baseline. In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of at least 5 millimeters (mm). Kaplan-Meier (K-M) method was used to estimate median PFS. 95% CI for median was computed using the method of Brookmeyer and Crowley.
- time origin
- Up to approximately 50 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT population included all randomized participants whether or not the assigned study treatment was received. As specified in the protocol, assessment of this outcome measure was limited to Arms A and B, as the objective was to compare pralsetinib with SOC platinum-containing anticancer treatment regimens.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-thoracic-neoplasm
- nct id
- NCT04222972
- outcome key
- om-0001
- source section id
- NCT04222972-om-0001
- source outcome index
- 1
- endpoint
- Arm A vs Arm B: Objective Response Rate (ORR)
- endpoint definition
- ORR was defined as the percentage of participants with a complete response (CR) or a partial response (PR) on two consecutive occasions ≥4 weeks apart, as determined by the investigator with the use of RECIST v1.1. CR was defined as disappearance of all target lesions or any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. 95% CI for rates were constructed using the Clopper-Pearson method. Percentages have been rounded off.
- time origin
- Up to approximately 50 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT population included all randomized participants whether or not the assigned study treatment is received. As specified in the protocol, assessment of this outcome measure was limited to Arms A and B, as the objective was to compare pralsetinib with SOC platinum-containing anticancer treatment regimens.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-thoracic-neoplasm
- nct id
- NCT04222972
- outcome key
- om-0002
- source section id
- NCT04222972-om-0002
- source outcome index
- 2
- endpoint
- Arm A vs Arm B: Overall Survival (OS)
- endpoint definition
- OS was defined as the time from randomization to death from any cause. K-M method was used to estimate median OS. 95% CI for median was computed using the method of Brookmeyer and Crowley.
- time origin
- From randomization to death (up to approximately 50 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT population included all randomized participants whether or not the assigned study treatment was received. As specified in the protocol, assessment of this outcome measure was limited to Arms A and B, as the objective was to compare pralsetinib with SOC platinum-containing anticancer treatment regimens.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-thoracic-neoplasm
- nct id
- NCT04222972
- outcome key
- om-0003
- source section id
- NCT04222972-om-0003
- source outcome index
- 3
- endpoint
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
- endpoint definition
- An AE is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.
- time origin
- Up to approximately 50 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Safety-evaluable population included all participants who receive any amount of any study drug.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-thoracic-neoplasm
- nct id
- NCT04222972
- outcome key
- om-0004
- source section id
- NCT04222972-om-0004
- source outcome index
- 4
- endpoint
- Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score
- endpoint definition
- ECOG is a 6-point scale (0-5) used to assess participants functional status, where, 0= Fully active, able to carry on all pre-disease performance without restriction; 1= restricted in physically strenuous activity but ambulatory \& able to carry out work of a light or sedentary nature, e.g., light housework, office work; 2= ambulatory \& capable of all self-care but unable to carry out any work activities. Up \& about more than 50% of waking hours; 3= capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5= dead.
- time origin
- Baseline up to 50 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Safety-evaluable population included all participants who receive any amount of any study drug. As specified in the protocol, assessment of this outcome measure was limited to the treatment period, as the objective was to compare pralsetinib with SOC platinum-containing anticancer treatment regimens.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-thoracic-neoplasm
- nct id
- NCT04222972
- outcome key
- om-0005
- source section id
- NCT04222972-om-0005
- source outcome index
- 5
- endpoint
- Arm A vs Arm B: Duration of Response (DOR)
- endpoint definition
- DOR was defined as the time from the first occurrence of a documented objective response (OR) to PD or death from any cause, whichever occurred first, as determined by the investigator with the use of RECIST v1.1. CR was defined as disappearance of all target lesions or any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. K-M method was used to estimate median DOR. 95% CI for median was computed using the method of Brookmeyer and Crowley.
- time origin
- Up to approximately 50 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT population included all randomized participants whether or not the assigned study treatment is received. Overall number analyzed is the number of participants with an objective response of CR or PR. As specified in the protocol, assessment of this outcome measure was limited to Arms A and B, as the objective was to compare pralsetinib with SOC platinum-containing anticancer treatment regimens.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-thoracic-neoplasm
- nct id
- NCT04222972
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm A: Treatment Period- SOC
- regimen
- Participants received platinum-containing anticancer treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating investigator based on NSCLC histology. Participants with NSCLC of non-squamous histology received carboplatin + pemetrexed or cisplatin + pemetrexed or pembrolizumab + carboplatin + pemetrexed or pembrolizumab + cisplatin + pemetrexed. Participants with NSCLC of squamous histology received carboplatin or cisplatin + gemcitabine or carboplatin + paclitaxel/nab-paclitaxel + pembrolizumab until PD or for up to a maximum of 2 years.
- analyzed count
- 113
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04222972-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-thoracic-neoplasm
- nct id
- NCT04222972
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Arm B: Treatment Period- Pralsetinib
- regimen
- Participants received pralsetinib, 400 mg, orally, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity, non-compliance, withdrawal of consent, closure of the study by the sponsor, or death, whichever occurred first (cycle length=21 days).
- analyzed count
- 110
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04222972-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-thoracic-neoplasm
- nct id
- NCT04222972
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Arm A: Treatment Period- SOC
- regimen
- Participants received platinum-containing anticancer treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating investigator based on NSCLC histology. Participants with NSCLC of non-squamous histology received carboplatin + pemetrexed or cisplatin + pemetrexed or pembrolizumab + carboplatin + pemetrexed or pembrolizumab + cisplatin + pemetrexed. Participants with NSCLC of squamous histology received carboplatin or cisplatin + gemcitabine or carboplatin + paclitaxel/nab-paclitaxel + pembrolizumab until PD or for up to a maximum of 2 years.
- analyzed count
- 113
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04222972-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-thoracic-neoplasm
- nct id
- NCT04222972
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Arm B: Treatment Period- Pralsetinib
- regimen
- Participants received pralsetinib, 400 mg, orally, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity, non-compliance, withdrawal of consent, closure of the study by the sponsor, or death, whichever occurred first (cycle length=21 days).
- analyzed count
- 110
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04222972-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-thoracic-neoplasm
- nct id
- NCT04222972
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Arm A: Treatment Period- SOC
- regimen
- Participants received platinum-containing anticancer treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating investigator based on NSCLC histology. Participants with NSCLC of non-squamous histology received carboplatin + pemetrexed or cisplatin + pemetrexed or pembrolizumab + carboplatin + pemetrexed or pembrolizumab + cisplatin + pemetrexed. Participants with NSCLC of squamous histology received carboplatin or cisplatin + gemcitabine or carboplatin + paclitaxel/nab-paclitaxel + pembrolizumab until PD or for up to a maximum of 2 years.
- analyzed count
- 113
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04222972-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-thoracic-neoplasm
- nct id
- NCT04222972
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Arm B: Treatment Period- Pralsetinib
- regimen
- Participants received pralsetinib, 400 mg, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity, non-compliance, withdrawal of consent, closure of the study by the sponsor, or death, whichever occurred first (cycle length=21 days).
- analyzed count
- 110
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04222972-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-thoracic-neoplasm
- nct id
- NCT04222972
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Arm A: Treatment Period- SOC
- regimen
- Participants received platinum-containing anticancer treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating investigator based on NSCLC histology. Participants with NSCLC of non-squamous histology received carboplatin + pemetrexed or cisplatin + pemetrexed or pembrolizumab + carboplatin + pemetrexed or pembrolizumab + cisplatin + pemetrexed. Participants with NSCLC of squamous histology received carboplatin or cisplatin + gemcitabine or carboplatin + paclitaxel/nab-paclitaxel + pembrolizumab until PD or for up to a maximum of 2 years.
- analyzed count
- 104
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04222972-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-thoracic-neoplasm
- nct id
- NCT04222972
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Arm B: Treatment Period- Pralsetinib
- regimen
- Participants received pralsetinib, 400 mg, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity, non-compliance, withdrawal of consent, closure of the study by the sponsor, or death, whichever occurred first (cycle length=21 days).
- analyzed count
- 108
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04222972-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-thoracic-neoplasm
- nct id
- NCT04222972
- outcome key
- om-0003
- arm key
- OG002
- arm label
- Arm C: Crossover Period- Pralsetinib
- regimen
- Participants with confirmed PD as confirmed by blinded independent central review (BICR) in Arm A crossed over to receive pralsetinib, 400 mg, orally, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity or death, whichever occurred first (cycle length=21 days).
- analyzed count
- 38
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04222972-om-0003#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-thoracic-neoplasm
- nct id
- NCT04222972
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Arm A: Treatment Period- SOC
- regimen
- Participants received platinum-containing anticancer treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating investigator based on NSCLC histology. Participants with NSCLC of non-squamous histology received carboplatin + pemetrexed or cisplatin + pemetrexed or pembrolizumab + carboplatin + pemetrexed or pembrolizumab + cisplatin + pemetrexed. Participants with NSCLC of squamous histology received carboplatin or cisplatin + gemcitabine or carboplatin + paclitaxel/nab-paclitaxel + pembrolizumab until PD or for up to a maximum of 2 years.
- analyzed count
- 104
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04222972-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-thoracic-neoplasm
- nct id
- NCT04222972
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Arm B: Treatment Period- Pralsetinib
- regimen
- Participants received pralsetinib, 400 mg, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity, non-compliance, withdrawal of consent, closure of the study by the sponsor, or death, whichever occurred first (cycle length=21 days).
- analyzed count
- 108
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04222972-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-thoracic-neoplasm
- nct id
- NCT04222972
- outcome key
- om-0004
- arm key
- OG002
- arm label
- Arm C: Crossover Period- Pralsetinib
- regimen
- Participants with confirmed PD as confirmed by blinded independent central review (BICR) in Arm A crossed over to receive pralsetinib, 400 mg, orally, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity or death, whichever occurred first (cycle length=21 days).
- analyzed count
- 38
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04222972-om-0004#groups/OG002
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-thoracic-neoplasm
- nct id
- NCT04222972
- harm key
- EG000
- source section id
- NCT04222972-ae
- event group key
- EG000
- event group label
- Arm A: Treatment Period- SOC
- serious affected
- 38
- serious at risk
- 104
- other affected
- 103
- other at risk
- 104
- frequency threshold
- 5
- collection period
- Up to approximately 50 months
- event definition
- All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-thoracic-neoplasm
- nct id
- NCT04222972
- harm key
- EG001
- source section id
- NCT04222972-ae
- event group key
- EG001
- event group label
- Arm B: Treatment Period- Pralsetinib
- serious affected
- 67
- serious at risk
- 108
- other affected
- 106
- other at risk
- 108
- frequency threshold
- 5
- collection period
- Up to approximately 50 months
- event definition
- All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-thoracic-neoplasm
- nct id
- NCT04222972
- harm key
- EG002
- source section id
- NCT04222972-ae
- event group key
- EG002
- event group label
- Arm C: Crossover Period- Pralsetinib
- serious affected
- 22
- serious at risk
- 38
- other affected
- 38
- other at risk
- 38
- frequency threshold
- 5
- collection period
- Up to approximately 50 months
- event definition
- All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice